Trulicity

Boxed warning

Trulicity has a boxed warning.¹ The drug is contraindicated for people with a personal or family history of medullary thyroid carcinoma, as well as those with multiple endocrine neoplasia syndrome type 2. Studies in rats indicate the drug may increase the risk of thyroid C-cell tumors (adenomas and carcinomas). Patients must be advised of the possible increased risk for medullary thyroid carcinoma and made aware of the associated symptoms.

Indicated uses of Trulicity:

• Improving glycemic control in people with type 2 diabetes who are on an appropriate diet and exercise plan

• Reducing the risk of major adverse cardiovascular events in people with type 2 diabetes who have known cardiovascular disease or risk factors

What is Trulicity (dulaglutide)?

Trulicity, or dulaglutide, is an injectable diabetes medication that belongs to a class of drugs called incretin mimetics. These drugs are prescribed for patients with type 2 diabetes to help regulate the release of insulin from the pancreas. They help lower blood glucose levels by increasing insulin production and also by slowing down the transit of food out of the stomach, which slows down glucose absorption into the bloodstream.² ³

What You Need To Know About Type 2 Diabetes

It’s essential to note that this medication is not suitable for people with type 1 diabetes. It’s also not a substitute for insulin therapy. Trulicity relies on your body’s ability to produce insulin and may not be suitable for you if you don’t have enough well-functioning insulin-producing cells in your pancreas.

What is Trulicity used to treat?

Type 2 diabetes mellitus develops when a person’s blood sugar levels are too high because their body makes too much insulin or uses it inefficiently. Managing blood sugar levels is essential for improving quality of life and reducing the risk of complications and diabetic emergencies.⁴ ⁵

Trulicity has been approved by the US Food and Drug Administration (FDA) for the following uses in people with type 2 diabetes:⁶ ⁷

• Improving blood sugar control when combined with a healthy diet and exercise plan (adults and children ten years of age and older)

• Reducing the risk of major adverse cardiovascular events (including stroke and heart attack) in those with known cardiovascular disease or multiple risk factors (adults)

Doctors may also prescribe this drug and other incretin mimetics off-label for weight loss. But this practice has created supply issues, and the medication has been placed on the FDA Drug Shortages list.⁸

How do you take Trulicity?

Trulicity is injected once weekly into the abdomen, thigh, or upper arm. A member of your care team will teach you to administer the injections, so you won’t need to go to the hospital for treatment each week. 

The injectable solution is housed inside a single-use pen, which you’ll store in the refrigerator until you’re ready to use.⁹

Using a Trulicity pen is fairly straightforward. You’ll uncap the pen, unlock it, and then push the button and hold to inject. You can use a particular injection area, such as your abdomen, repeatedly. However, it is best to inject in a different spot within the injection area each time you take it.¹⁰

Trulicity can’t be mixed with insulin in a single syringe. It is acceptable to administer both insulin and Trulicity around the same time, but they should not be injected in a location near one another.¹¹

You should try to use Trulicity on the same day each week to maintain a consistent amount of medication in your body.

Never share injection pens under any circumstances, and don’t use your single-use pen more than once.

Your doctor’s prescribed diet and exercise plan are as important as medications. Follow your doctor’s directions carefully and consistently to achieve optimal blood sugar control.

Dosage forms and strengths

Trulicity pens are available in several strengths. Your doctor will decide which dose is best for you. The pens are available in the following concentrations:¹²

• 0.75mg/0.5mL

• 1.5mg/0.5mL

• 3.0mg/0.5mL

• 4.5mg/0.5mL

Follow your doctor’s advice precisely, even if your dosage falls outside the typical range. Don’t adjust your dose without consulting your doctor. 

Seeing results

Trulicity reaches maximum concentrations in the blood within 24–72 hours, and its action continues for about a week. However, it may take two to four weeks to achieve steady levels.¹³

Who should not take Trulicity?

As stated in the boxed warning, Trulicity is contraindicated in people with a personal or family history of medullary thyroid carcinoma and those with multiple endocrine neoplasia syndrome type 2 (MEN 2). In addition, patients with a previous severe hypersensitivity reaction to any of the medication’s active or inactive ingredients should not use this drug. 

Additionally, Trulicity should be prescribed cautiously for people who:¹⁴

• Have pancreatitis. It’s not known if Trulicity is safe for people with pancreatitis. Your doctor will weigh the potential risks against the potential benefits. Several study participants who were taking this drug developed pancreatitis. Patients taking Trulicity should be monitored for symptoms of the condition and stop taking the medication as soon as these symptoms occur.

• Take insulin or other medications that increase insulin production. The risk of low blood sugar is higher in people taking multiple drugs targeting blood sugar levels. While these medicines can be used alongside Trulicity, lower doses may be necessary.

• Have severe gastrointestinal disease. This medication can cause gastrointestinal side effects, which may be severe. More research is needed to determine if the drug is safe for people with existing gastrointestinal diseases, such as inflammatory bowel disease and obstruction.¹⁵

• Have acute kidney injury. There are reports linking Trulicity to acute kidney failure and worsening chronic kidney disease. Close monitoring of kidney function is essential in these patients.

• Have a history of diabetic retinopathy. There’s evidence that fast improvement in blood sugar control may be associated with a temporary worsening of this condition. People with diabetic retinopathy who take Trulicity will need close monitoring for progression.

Potential side effects of Trulicity

Trulicity may cause unwanted side effects. Most are mild and resolve without intervention, but others may be severe and lasting. Some known side effects are outlined below, but these lists are not exhaustive. If you experience any unusual symptoms while taking this medication, speak with your doctor.¹⁶ ¹⁷

Common side effects associated with Trulicity include:

• Nausea, vomiting

• Heartburn, burping

• Diarrhea, constipation

• Decreased appetite, weight loss

• Tiredness

• Intestinal gas, bloating

• Abdominal pain

• Injection site reactions

Less frequently, people taking Trulicity experience severe side effects. If you experience any of the following serious side effects while taking this medication, seek urgent medical care. Severe side effects include:

• Vision changes

• Fast heartbeat

• Swelling of the lips, tongue, face, or throat

• Difficulty breathing or swallowing

• Hives, rash, or itching

• Persistent pain in the upper left or middle of the abdomen that may spread to the back (indicating possible pancreatitis)

• Low blood sugar

• Kidney failure or worsening kidney disease

• Hepatitis

• Pancreatitis

• Gallstones

Overdoses

Using more Trulicity than prescribed can be harmful. If you’ve taken too much of this medication, seek emergency medical care.

Signs of an overdose may include:¹⁸

• Nausea

• Vomiting

• Signs of severely low blood sugar (including shakiness, chills, lightheadedness, confusion, and others)

Missed doses

If you miss your dose but remember it later in the day, take it as soon as you remember. If you’re one to four days late, take your missed dose and resume your weekly schedule. However, if there are fewer than 72 hours until your next scheduled dose, skip the missed one, and continue your regular dosing schedule.¹⁹ ²⁰

Do not double your dose to make up for a missed one.

Allergy information

Some people are allergic to Trulicity. In some cases, allergic reactions are severe. Stop taking this medication and seek immediate medical care if you experience any of the following symptoms of a severe drug allergy:²¹

• Swelling of the face, lips, tongue, or throat

• Severe rash, itching

• Difficulty breathing

• Trouble swallowing

• Vomiting

• Dizziness

• Fainting, loss of consciousness

• Fast heartbeat

Long-term use of Trulicity

Trulicity is intended for long-term use. It can be beneficial in helping lower your risk of complications from diabetes as well as cardiovascular disease. Research shows many patients experience moderate and sustained weight loss while taking this drug, which further reduces the risks associated with diabetes. If the medication works well for you and helps you achieve your target blood sugar levels, your doctor will advise you to continue taking it.²²

Trulicity in pregnancy and breastfeeding

There’s not enough high-quality research to know if Trulicity is safe during pregnancy, but animal studies indicate there may be risks. However, poorly controlled diabetes is associated with a range of severe pregnancy-related complications in both the mother and the fetus. The US FDA recommends using Trulicity during pregnancy only if the potential benefits justify the potential risks.²³

There are no adequate studies in humans or animals to determine if Trulicity passes through breast milk. 

If you’re pregnant, planning, or breastfeeding, discuss your concerns with your doctor before taking this medication.

Interactions with other drugs

Trulicity can be used in conjunction with other medications. However, you should check with your doctor before starting any new drugs to ensure none of the medications you take interact to produce unwanted effects. When starting Trulicity, there are two significant types of interactions to consider. The first is when you are taking other drugs to lower your blood sugar, like insulin, which can cause hypoglycemia due to their additive effects. Secondly, the absorption of other medications can be reduced because Trulicity slows your stomach from emptying its contents.²⁴ ²⁵

The following drugs are known to interact with Trulicity:

• Insulin and other drugs for regulating blood sugars such as glyburide (Glynase, Micronase), glipizide (Glucotrol), nateglinide, repaglinide

• Drugs for multiple sclerosis, including fingolimod (Gilenya), ozanimod (Zeposia), ponesimod (Ponvory), and siponimod (Mayzent)

• Clonidine (Kapvay, Catapres)

• Lofexidine (Lucemyra)

Can I drink alcohol while taking Trulicity?

There are no known direct interactions between this medication and alcohol. However, you should consider the following:

• Signs of intoxication can mimic signs of low blood sugar, and it may be challenging to distinguish between the two.

• Alcohol can affect your blood sugar levels for up to 12 hours.

• Alcohol may not be safe for you if your diabetes is not well-controlled.

What to discuss with your doctor before starting Trulicity

Trulicity is available by prescription only, so you’ll need to meet with your doctor before you start taking it. At your appointment, you should discuss the following topics:²⁶ ²⁷

• Any medication allergies you have

• All medications, supplements, or herbs you take regularly or occasionally

• Your diet and exercise habits

• Proper techniques for self-injecting

• Any plans relating to pregnancy or breastfeeding

Additionally, you should inform your doctor of all medical conditions you have, especially if you have any of the following:

• Medullary thyroid carcinoma (or family history)

• Multiple endocrine neoplasia syndrome type 2 (or family history)

• Acute kidney injury

• Pancreatitis

• Diabetic retinopathy

• Severe gastrointestinal disease or digestive problems

Ask your doctor what to do when you get sick, are unable to eat (fasting for a test, procedure, or another reason), experience unusual stress, are injured, need surgery, or become ill. These conditions can affect the amount of medication you may require.

Stopping Trulicity

Stopping Trulicity does not cause withdrawal symptoms. However, if you stop taking this medication when you need it, your glycemic control may worsen. Speak with your doctor about how to stop Trulicity safely.

Drug approval history

2014: The US FDA granted initial approval (0.75mg and 1.5mg doses only) for improving glycemic control in type 2 diabetes mellitus.²⁸

2020: The FDA approved 3.0mg and 4.5mg doses, and Trulicity was approved for reducing the risk of cardiovascular events in patients with type 2 diabetes who have known cardiovascular disease or significant risk factors.²⁹

2022: The FDA approved Trulicity for improving blood sugar control in children aged ten years and older.³⁰

Tips for taking Trulicity

• Each pen contains one ready-to-use dose, don’t try to reuse your pens.

• Rotate injection sites to minimize skin irritation.

• If you’re unsure about self-injecting, don’t hesitate to ask your healthcare team for another demonstration. Additional guidance is available on the manufacturer’s website.

• Do not share your Trulicity pen with another person, as sharing could spread infection. Remember, your pen may not contain the same dose as someone else’s, so don’t share unused pens, either.

• Store your medication in the refrigerator, but don’t freeze it. If you’re traveling, you can keep your pens at room temperature for up to 14 days.³¹

• Dispose of your used pens in a sharps container or another secure container.

Frequently asked questions

Is Trulicity the same as Ozempic?

The drugs belong to the same class and work the same way, but Trulicity is the branded form of the generic drug dulaglutide, while Ozempic contains a different active ingredient called semaglutide.

Is Trulicity insulin?

No, Trulicity is not the same as insulin, and it’s not a replacement for insulin therapy. Trulicity is a medication that helps your body better process the insulin it produces.

What foods should I avoid while on Trulicity?

If you have diabetes, you need to eat a diabetes-friendly diet, regardless of whether or not you’re taking Trulicity. Your doctor will work with you to develop an appropriate diet that helps to support your glucose control and keep your weight within the healthy range.